false 0001504167 0001504167 2023-06-20 2023-06-20
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported): June 20, 2023
 ​
TIMBER PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
  
001-37411
  
59-3843182
(State or other jurisdiction
of incorporation)
  
(Commission
File Number)
  
(IRS Employer
Identification No.)
 
3 Mountainview Road, Suite 100
Warren, NJ 07059
(Address of principal executive offices)
Registrant’s telephone number, including area code: (908) 636-7160
 
N/A
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
☐
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
  
Trading Symbol(s)
  
Name of each exchange on which registered
Common Stock, $0.001 Par Value
​
TMBR
​
The NYSE American LLC
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 ​ ​
 
 
 
​Item 7.01
Regulation FD.
 
On June 20, 2023, Timber Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that interim pharmacokinetic (PK) analyses from the Phase 3 ASCEND study indicate minimal systemic absorption of isotretinoin or its major metabolites in patients with moderate to severe forms of congenital ichthyosis (CI) who were treated with TMB-001 0.05% ointment. A copy of the press release is attached hereto as Exhibit 99.1.
 
The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibit 99.1, is being furnished to the Securities and Exchange Commission, and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by a specific reference in such filing.
 
Item 8.01
Other Events.
 
On June 20, 2023, the Company announced that interim PK analyses from the Phase 3 ASCEND study indicate minimal systemic absorption of isotretinoin or its major metabolites in patients with moderate to severe forms of CI who were treated with TMB-001 0.05% ointment. Full PK results will be presented during the Society for Pediatric Dermatology’s Annual Meeting to be held July 13-16, 2023, in Asheville, North Carolina.
 
Item 9.01
Financial Statements and Exhibits.
 
(d) Exhibits
 
As described above, the following exhibits are furnished as part of this report:
 
Exhibit
No.
  
Description
     
99.1
  
104
  
Cover Page Interactive Data File (embedded within the Inline XBRL document)
 
 
 
 
​​SIGNATURE
 ​
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 ​
 ​
 
TIMBER PHARMACEUTICALS, INC. 
   
Date: June 20, 2023
By:
/s/ John Koconis
 
Name:
John Koconis
 
Title:
Chief Executive Officer and Chairman of the Board of Directors
 ​
 
 

Exhibit 99.1

 

Timber Pharmaceuticals to Present Interim Analyses from Phase 3 ASCEND Study of TMB-001 in Congenital Ichthyosis

 

- First presentation of data from Phase 3 ASCEND study will feature pharmacokinetic results that indicate minimal systemic absorption of isotretinoin -

 

- Data to be presented at the Society for Pediatric Dermatology’s Annual Meeting -

 

WARREN, NJ, June 20, 2023 – Timber Pharmaceuticals, Inc. ("Timber" or the “Company”) (NYSE American: TMBR), a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases, today announced that interim pharmacokinetic (PK) analyses from the Phase 3 ASCEND study indicate minimal systemic absorption of isotretinoin or its major metabolites in patients with moderate to severe forms of congenital ichthyosis (CI) who were treated with TMB-001 0.05% ointment. Full PK results will be presented during the Society for Pediatric Dermatology’s Annual Meeting to be held July 13-16, 2023, in Asheville, North Carolina.

 

“Many dermatologists are familiar with oral isotretinoin, but high-dose and chronic oral isotretinoin therapy required in the treatment of CI cannot be tolerated by many patients due to systemic toxicity,” said Alan Mendelsohn, M.D., Chief Medical Officer of Timber. “We are advancing innovative clinical research evaluating TMB-001, a topical isotretinoin formulated using our proprietary IPEG™ delivery system that enables targeted delivery to the epidermis and dermis with the potential to minimize systemic drug absorption, which we hope will translate into better safety and lower systemic toxicity while still maintaining high degrees of efficacy.”

 

The Phase 3 ASCEND study (https://ichthyosistrial.com/about_ascend_study.htm) is an ongoing double-blind, vehicle-controlled randomized 12-week study followed by 12 weeks of open label treatment of patients who are greater than 6 years of age with moderate to severe X-linked recessive CI (XLRI) or autosomal recessive CI (ARCI). The primary endpoint is the difference in proportions of treated patients with 2-point Investigator's Global Assessment (IGA) scaling/fissuring score improvement from baseline at 12 weeks. A subset of patients is also participating in a 12-week open label Maximal Use Study (MuST) that includes the collection of PK data as well as safety and efficacy data.

 

The interim PK analyses include the first nine patients who completed 15 days of the MuST study. The results indicate minimal absorption of isotretinoin when TMB-001 0.05% is applied to 75-90% of the body surface area. The 9 subjects (7 ARCI, 2 XLRI; ages 12-62) demonstrated mean plasma concentrations (ng/mL) of isotretinoin at Day 14 of 4.83 (range: 1.46-16.59), 4-oxo-isotretinoin of 13.71 (6.52-47.86), tretinoin of 0.08 (0-0.66) and 4-oxo-tretinoin of 0.

 

“The dry, thickened, and scaling skin that people living with these rare genetic keratinization disorders must deal with can be seriously debilitating, especially in the most severe cases of XLRI and ARCI,” said Joyce M.C. Teng, M.D., Ph.D., Professor and Director of Pediatric Dermatology, Stanford University. “If we can overcome toxicity challenges of oral treatment with a novel topical formulation of isotretinoin, we may be able to provide better care for our patients. These interim PK data are encouraging, especially when we compare the results to plasma isotretinoin concentrations that we typically see on the labels of oral therapies, which are as high as 862ng/mL with a single dose of 80mg of isotretinoin.”

 

 
Exhibit 99.1

 

Timber has received both Breakthrough Therapy Designation and Fast Track Status from the U.S. Food and Drug Administration for TMB-001.

 

About Timber Pharmaceuticals, Inc.

 

Timber Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of treatments for rare and orphan dermatologic diseases. The Company's investigational therapies have proven mechanisms-of-action backed by decades of clinical experience and well-established CMC (chemistry, manufacturing, and control) and safety profiles. The Company is initially focused on developing non-systemic treatments for rare dermatologic diseases including congenital ichthyosis (CI) and sclerotic skin diseases. For more information, visit www.timberpharma.com.

 

Forward-Looking Statements

 

This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's product development, clinical and regulatory timelines, market opportunity, competitive position, intellectual property rights, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

 

These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential, "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, as well as other documents filed by the Company from time to time thereafter with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

 

For more information, contact:

 

Timber Pharmaceuticals, Inc.
John Koconis
Chairman and Chief Executive Officer
jkoconis@timberpharma.com

 

Investor Relations:
Stephanie Prince
PCG Advisory
(646) 863-6341
sprince@pcgadvisory.com

 

Media Relations:
Adam Daley
Berry & Company Public Relations
(212) 253-8881
adaley@berrypr.com